Financial Performance - The company reported a significant increase in revenue, achieving $500 million in Q4 2023, representing a 25% year-over-year growth[14] - The company anticipates a revenue growth of 20% for the next fiscal year, projecting $600 million in total revenue[16] - The company reported a decrease in operational expenses by 5%, improving overall profitability margins[16] User Growth - User data showed a 15% increase in active users, reaching 2 million by the end of the quarter[16] Product Development - New product launches are expected to contribute an additional $100 million in revenue, with a focus on innovative technologies[16] - The company has secured exclusive license rights to Toll-like Receptor 5 Agonists, which is expected to enhance its product portfolio significantly[16] - The company plans to invest $50 million in research and development for new technologies and product enhancements[16] Market Strategy - Market expansion efforts are underway, targeting a 10% increase in market share in the next year[16] - Strategic partnerships are being explored to enhance distribution channels and improve market penetration[16] Financial Strategy - Future guidance indicates a focus on maintaining a strong cash position, with an aim to secure additional financing if necessary[16]

Financing and Stock Issuance - The Company plans to issue and sell up to $25,000,000 of its Common Stock to the Investor[4] - The minimum amount for each Put is set at $50,000, while the maximum is capped at $500,000 or 100% of the Average Daily Trading Value[42] - The Initial Purchase Price for shares will be 95% of the VWAP on the Trading Day preceding the Put Date, adjusted to 85% if the Principal Market is any tier of the OTC Markets[20] - The Commitment Shares consist of 29,800 restricted shares of Common Stock to be issued to the Investor upon the execution of the Agreement[11] - The Company must deliver the Put Shares as DWAC Shares within one Trading Day following the Put Date[44] - If the Company fails to deliver the Put Shares, it must compensate the Investor for any losses incurred due to a Buy-In[44] - The Commitment Period lasts for 24 months from the Execution Date or until the Maximum Commitment Amount is reached[10] - The Purchase Price for the respective Put Shares will be established at the end of the Valuation Period[43] - The Company is required to provide a written notice to the Investor regarding any amounts payable in respect of a Buy-In[44] - The Agreement includes provisions for the Investor to pursue additional remedies in case of the Company's failure to deliver shares timely[44] - The Company has not issued any capital stock since its most recently filed periodic report, except for employee stock options and employee stock purchase plans[59] - The Company is maintaining a reserve of Common Stock equal to the Required Minimum as per the agreement[74] - The Company is committed to securing the listing of all Put Shares and Commitment Shares on the Principal Market[75] - The Company will not enter into any other Equity Line of Credit without the Investor's prior written consent[76] - The Company must file a Current Report on Form 8-K with the SEC regarding the transactions contemplated by the agreement[77] - The Company must ensure that the lowest traded price of the Common Stock in the ten Trading Days preceding the Put Date exceeds $0.01 per share[93] - The Company must maintain compliance with all applicable securities laws and regulations during trading activities[71] - The Company is required to reserve the Required Minimum for the Investor's benefit under the agreement[92] - The Company must ensure that no Bankruptcy Proceedings are initiated against it or any subsidiary[94] Company Performance and Growth - The company reported a significant increase in revenue, achieving $96.77 billion in the September quarter, marking a record for iPhone sales[110] - The company experienced a year-over-year growth of 15% in user data, indicating a strong customer retention and acquisition strategy[110] - Future outlook includes a projected revenue growth of 10% for the next fiscal year, driven by new product launches and market expansion initiatives[110] - The company is investing heavily in research and development, with a budget increase of 20% aimed at enhancing product innovation and technology[110] - Market expansion efforts are focused on increasing presence in Asia, with a target of capturing an additional 5% market share by the end of the next fiscal year[110] - The company is exploring potential acquisitions to bolster its technology portfolio, with a budget of $500 million allocated for strategic investments[110] - New product lines are expected to launch in Q2 2024, anticipated to contribute an additional $1 billion in revenue[110] - The company has set a goal to reduce operational costs by 15% over the next two years through efficiency improvements[110] - Customer satisfaction ratings have improved, with a reported increase of 12% in positive feedback from users[110] - The company plans to enhance its digital marketing strategy, aiming for a 25% increase in online engagement metrics[110] - The company reported a revenue of $1.2 billion for Q3 2023, representing a 15% increase year-over-year[110] - User growth reached 5 million new subscribers in the last quarter, bringing the total to 50 million active users[110] - The company expects revenue guidance for Q4 2023 to be between $1.3 billion and $1.5 billion, indicating a potential growth of 8% to 25%[110] - New product launches are anticipated to contribute an additional $200 million in revenue by the end of Q4 2023[110] - The company is investing $50 million in R&D for new technologies aimed at enhancing user experience[110] - Market expansion efforts include entering three new international markets, projected to increase user base by 10%[110] - The company has completed a strategic acquisition of a tech startup for $100 million to bolster its product offerings[110] - Cost reduction strategies are expected to save approximately $30 million annually, improving overall profitability[110] - The company plans to enhance its marketing budget by 20% to support new product launches and market penetration[110] - Future outlook remains positive with a projected annual growth rate of 12% over the next three years[110] Agreement and Legal Provisions - The Company issued Commitment Shares to the Investor upon the execution of the Agreement, which are not contingent upon any other event or condition[119] - The Company will pay $17,500.00 to the Investor for reimbursement of expenses related to the preparation of the Agreement[119] - The Agreement allows the Company to terminate at any time by written notice, except during any Valuation Period or while the Investor holds any Put Shares[117] - The Investor is entitled to recover reasonable attorney's fees and costs if they prevail in any action or dispute related to the Agreement[113] - The Company and Investor consent to exclusive venue for arbitration in the Commonwealth of Massachusetts[112] - The Company certifies that all conditions precedent to the Investor's obligation to purchase Put Shares have been satisfied as of the Condition Satisfaction Date[138] - The Agreement contains provisions for equitable relief, allowing the Investor to seek injunctive relief without proving actual damages[124] - The Company waives any objection to jurisdiction and venue in any action instituted under the Agreement[112] - The Agreement supersedes all prior agreements and understandings between the Company and the Investor[118] - The Company acknowledges that the Agreement may be deemed a "material contract" and may need to be filed as an exhibit to reports or registration statements[127] - The exclusive venue for arbitration of any disputes is in the Commonwealth of Massachusetts[141] - All claims must be submitted to arbitration conducted exclusively in Massachusetts[142] - The arbitration award will be final and binding, and promptly payable in US dollars free of any tax or deduction[142] - The parties agree to incorporate the Massachusetts Uniform Arbitration Act into the arbitration provisions[143] - Arbitration may be initiated by giving written notice, and the notice must describe the nature of the controversy and remedies sought[144] - Each party must select a neutral arbitrator from a list of three proposed arbitrators within specified timeframes[145][146] - The cost of the arbitrator will be shared equally by both parties, with provisions for advancing unpaid amounts[150] - Discovery will be limited, with specific caps on the number of interrogatories, requests for admission, and document requests[155] - Each party may submit expert reports within sixty days of the arbitration commencement date, with a maximum of two experts allowed[158] - Dispositive motions may be submitted according to the Massachusetts Rules of Civil Procedure, with specific timelines for responses[159]

Product Development and Research - Tivic Health's ClearUP product is the first FDA-approved bioelectronic treatment for sinus pain and congestion, with U.S. FDA clearance granted in January 2019 and expanded in March 2021[112][113]. - Tivic Health entered into a Collaboration and Research Support Agreement with The Feinstein Institutes for Medical Research to optimize responses in Autonomic Nervous System function, with a project length of one year[120]. - The company has identified approximately 30 potential medical use cases for its non-invasive vagus nerve stimulation (ncVNS) technology in various disease areas[122]. - Tivic Health's non-invasive cervical vagus nerve stimulation approach showed a 97% increase in heart rate variability and significant changes in brain activity during clinical research[118][119]. - The company launched ClearUP 2.0, which includes new power management circuitry for faster charging and longer battery life[136]. - The company plans to increase research and development investments in its vagus nerve platform and clinical applications in 2024[153]. Financial Performance - Revenue for the three months ended September 30, 2024, decreased by $156 thousand, or 56%, compared to the same period in 2023, primarily due to a 55% decrease in the number of units sold[140]. - For the nine months ended September 30, 2024, revenue decreased by $219 thousand, or 27%, compared to the same period in 2023, primarily due to a 36% decrease in unit sales, offset by a 13% increase in the per unit average sales price[140]. - Cost of sales for the three months ended September 30, 2024, decreased by $92 thousand, or 53%, compared to the same period in 2023, primarily driven by the decrease in unit sales[143]. - Gross profit for the three months ended September 30, 2024, was $44 thousand, a decrease of $64 thousand compared to the same period in 2023[138]. - Research and development expenses for the three months ended September 30, 2024, increased by $85 thousand compared to the same period in 2023, while for the nine months, they decreased by $315 thousand[147]. - Sales and marketing expenses for the three months ended September 30, 2024, decreased by $246 thousand compared to the same period in 2023, and for the nine months, they decreased by $444 thousand[149]. - General and administrative expenses for the three months ended September 30, 2024, decreased by $232 thousand compared to the same period in 2023, and for the nine months, they decreased by $1.2 million[150]. - As of September 30, 2024, the company had cash and cash equivalents of $2.2 million and an accumulated deficit of $42.1 million[151]. - The company has incurred an accumulated deficit of $42.1 million through September 30, 2024, and expects to incur additional losses in the future as it expands research and development activities[157]. - Cash used in operating activities for the nine months ended September 30, 2024, was $4.4 million, compared to $6.7 million for the same period in 2023[162][163]. - The company generated $3.2 million from financing activities during the nine months ended September 30, 2024, primarily from the sale of 4,710,000 shares of common stock[165]. Operational Changes and Agreements - The company expects a reduction of approximately $200,000 in lease expenses over the next year and a half following the termination of a sublease agreement[126]. - The company has transitioned to third-party logistics and in-house assembly capabilities after terminating its Fulfillment Services Agreement with ALOM Technologies Corporation[128]. - The Amended and Restated 2021 Equity Incentive Plan increased the number of shares authorized for issuance from 92,376 to 1,000,000 shares, approved by stockholders on August 9, 2024[135]. - The company entered into an Equity Distribution Agreement allowing for the sale of up to $10 million in shares of common stock, with only $18 thousand in gross proceeds utilized to date[151]. - The company has remaining commitments to pay a total of $231 thousand for milestones related to the development of Tivic's ncVNS technology, expected to be incurred over the next six months[179]. - The company has entered into a Co-Working Space Agreement for $1 thousand a month, with an initial term of six months[178]. Market and Economic Conditions - A 2023 study indicated that approximately 85 million U.S. adults experience inflammation-related symptoms, with 58% of sufferers trying to avoid medication[114]. - Global supply chain shortages and inflation may increase the cost of components, potentially decreasing gross margins or necessitating price increases[168]. - Global issues and macroeconomic factors have made it difficult to accurately forecast revenues and financial results, with potential for significant market disruptions[172]. - Inflation has increased recently, with potential adverse effects on operating results due to rising costs of products and services[174]. - The company continues to monitor geopolitical tensions and their potential impacts on operations and supply chains[173]. - The company has not been materially impacted by ongoing military conflicts, but the extent of future impacts remains unpredictable[171]. Compliance and Future Outlook - The company is actively monitoring its stock price to regain compliance with Nasdaq's minimum bid price requirement by December 26, 2024[132][134]. - The company anticipates that operating expenses will increase significantly as it seeks regulatory approval and commercializes new products[152][153]. - The company expects that its cash and financial resources may be insufficient to meet anticipated needs for the next twelve months, raising substantial doubt about its ability to continue as a going concern[152][157]. - The company has faced significant costs associated with operating as a public company and expects to continue incurring losses for the foreseeable future[154]. - The company has not generated significant revenue from product sales and plans to finance operations through equity or debt financings until substantial revenue is achieved[160]. - There were no changes in internal control over financial reporting that materially affected the company's reporting[185]. - The company is not currently a party to any legal proceedings that would materially affect its business[187]. - The company may consider strategic acquisitions or transactions that align with its growth plan, which could require a substantial portion of its cash reserves[155][156].

Financial Data and Key Metrics Changes - ClearUP revenues for Q2 2024 were $140,000, a decrease of $63,000 or 12% compared to the first half of 2023, primarily due to a 27% decrease in unit sales, offset by a 20% increase in the per-unit average sale price [6][9] - Gross profits for the first half of 2024 were $197,000, showing margin improvement to 42% compared to 32% in 2023 [7] - The company incurred a net loss of $1.3 million for Q2 2024, which is an improvement from a net loss of $2.1 million in 2023 [9] - Cash and cash equivalents totaled $3.7 million as of June 30, 2024, compared to $3.4 million at the end of 2023 [9] Business Line Data and Key Metrics Changes - Cost of sales for Q2 2024 was $110,000, a decrease of $86,000 or 24% compared to the first half of 2023, driven by reduced sales volume and cost improvements [7] - Total operating expenses for Q2 2024 were $1.2 million, down from $2.2 million in 2023, reflecting a year-over-year cost reduction of $1.5 million [8] Company Strategy and Development Direction - The company is focusing on developing a novel vagus nerve stimulation (VNS) system, which is a critical part of its strategy to build shareholder value [5][6] - The company aims to broaden its footprint in bioelectronic medicine, leveraging learnings from its first product to target high-value medical applications [13][35] - The company is prioritizing noninvasive VNS, which is expected to have lower costs and risks compared to implanted devices, allowing for quicker market entry [22][26] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the macro environment, including increased supply chain costs and tighter marketing restrictions, which may limit short-term profitability of the ClearUP product [12] - The company is optimistic about the potential of its VNS program, with plans to validate market opportunities and optimize applications for strong commercial results [34][35] - Management emphasized the importance of transparency with investors regarding future plans and the potential for significant shareholder returns from the VNS program [13][35] Other Important Information - The company received a notification from NASDAQ regarding non-compliance with the minimum bid price requirement, with a 180-day period to regain compliance [10] - The company has a robust patent portfolio with nine issued patents and ten pending patents, which are crucial for protecting its innovations in VNS [41][42] Q&A Session Summary Question: What is the company planning to do with ClearUP as it turns towards VNS? - Management indicated that while ClearUP is a valuable product, the focus will shift towards exploring alternative monetization strategies, including licensing and international distribution agreements [39][40] Question: Does the company have resources to move forward with the VNS program? - Management confirmed that while operational cutbacks have been made, the research pipeline is crucial for building shareholder value, and there will be a need to expand the clinical research team as the program progresses [40] Question: What diseases is the company considering targeting based on the VNS study? - Management stated that there is a prioritized list of potential targets, but specific indications are not ready to be communicated publicly yet [41] Question: Are there any patents pending, and what is the risk of expiration? - Management confirmed the existence of a robust patent portfolio with no immediate risk of expiration, as the patents are newly issued and the company expects to bring products to market quickly [42]

Revenue and Profitability - Revenue for Q2 2024 was $140 thousand, a decrease of 12% compared to Q2 2023, primarily due to a 27% decrease in unit sales, offset by a 20% increase in average sales price per unit [6]. - Gross profit for the first half of 2024 was $197 thousand, compared to $174 thousand in the same period of 2023, with a gross margin of 42% in 2024, up from 32% in 2023 [6]. - The company reported a net loss of $2.7 million for the first half of 2024, which is $1.5 million lower than the net loss of $4.2 million in the same period of 2023 [7]. Operating Expenses - Total operating expenses for the first half of 2024 were $2.9 million, a reduction of $1.5 million compared to $4.4 million in the first half of 2023 [7]. Product Development and Launches - Tivic launched ClearUP 2.0, which includes new power management circuitry for faster charging and longer battery life, addressing previous customer complaints [4]. - Tivic's Phase 1 trial of non-invasive vagus nerve stimulation (VNS) showed promising results, indicating potential clinical utility in major disease areas [2]. Strategic Partnerships and Agreements - The company entered a limited exclusive distribution agreement with a top 10 medical equipment distributor in the U.S. [4]. Financial Position and Future Outlook - The company raised approximately $4.0 million through a public offering of 4,710,000 shares at a price of $0.85 per share [7]. - Cash and cash equivalents as of June 30, 2024, totaled $3.7 million, an increase from $3.4 million at the end of 2023 [7]. - The company expects future growth to be significantly enhanced by advancements in its vagus nerve stimulation program [3].

Core Viewpoint - Tivic Health Systems' stock has experienced significant volatility, with a recent rally attributed to a patent update, leading to a notable increase in trading volume and share price [4][6]. Group 1: Stock Performance - Tivic Health Systems' stock (TIVC) rose by 38.9% as of Monday morning, although it remains down 64.8% year-to-date and 87% over the past 12 months [7]. - The trading volume for TIVC reached approximately 68 million shares on Monday, compared to the daily average of about 2.9 million shares [1]. Group 2: Recent Developments - The recent rally in TIVC stock was initially driven by a patent update, which significantly boosted the stock during normal trading hours on Thursday [4]. - Best Growth Stocks, an equity research firm utilizing artificial intelligence, provided an analysis regarding the implications of the latest patent news for Tivic Health Systems [2].

Tivic Health Systems, Inc. (NASDAQ:TIVC) Q1 2024 Earnings Conference Call May 15, 2024 4:30 PM ET Company Participants Jennifer Ernst – Chief Executive Officer Kimberly Bambach – Interim Chief Financial Officer Conference Call Participants Operator Welcome to the Tivic Health Systems' First Quarter 2024 Financial Results and Shareholder Update Conference Call. All participants will be in listen-only mode. Please note that the conference is being recorded. Statements made during this call contain forward-loo ...

Financial Performance - For Q1 2024, revenue decreased by $42 thousand, or 11.2%, to $334 thousand compared to Q1 2023, primarily due to a 35% decrease in unit sales, offset by a 35% increase in the average sales price per unit [132][134]. - Cost of sales decreased by $96 thousand, or 37%, to $167 thousand in Q1 2024, driven by lower sales volume, with variable costs at $133 thousand, or $74.32 per unit [132][136]. - Gross profit increased by $54 thousand to $167 thousand in Q1 2024, reflecting improved pricing strategies despite lower sales volume [132]. - The company incurred a net loss of $1.5 million for the three months ended March 31, 2024, compared to a net loss of $2.1 million for the same period in 2023 [159][160]. - Cash used in operating activities for the three months ended March 31, 2024 was $1.7 million, a decrease from $2.4 million in the same period of 2023 [158]. Expenses - Research and development expenses decreased by $234 thousand to $256 thousand in Q1 2024, attributed to reduced headcount and non-recurring expenses from 2023 [132][141]. - Sales and marketing expenses increased by $47 thousand to $505 thousand in Q1 2024, primarily due to a test program focused on educating healthcare professionals about the ClearUP solution [132][143]. - General and administrative expenses decreased by $394 thousand to $887 thousand in Q1 2024, due to reduced headcount and lower consulting fees [132][145]. - The company expects operating expenses to increase significantly as it develops additional product candidates and seeks regulatory approval [147]. Cash and Capital - As of March 31, 2024, the company had cash and cash equivalents of $1.7 million, working capital of $1.8 million, and an accumulated deficit of $39.4 million [146]. - The company raised approximately $3.5 million in net proceeds from a public offering of common stock and warrants in May 2024 [125]. - The company generated net proceeds of approximately $3.6 million from the sale of 200,000 shares of common stock in February 2023 and approximately $4.3 million from the sale of 1,169,230 shares from July to August 2023 [146]. - The company may need to raise additional capital to continue operations and fund planned activities, including research and development and commercialization of future product candidates [154][157]. Product Development and Launches - Tivic Health launched ClearUP 2.0, featuring improved power management for faster charging and longer battery life [128][129]. - A clinical trial is ongoing to evaluate the use of Tivic's handheld platform for managing pain from facial surgeries, which may lead to new product development [122]. - The company plans to increase research and development investments in its vagus nerve platform and clinical applications in 2024 [148]. Market and Economic Conditions - The ongoing military conflicts, particularly between Russia and Ukraine and Israel and Hamas, have led to significant volatility in global markets, affecting commodity prices and supply chains [166]. - The company has not yet experienced material impacts from these conflicts, but the unpredictability of their duration and effects poses risks to operations and supply chains [167]. - Macroeconomic factors, including inflation and high interest rates, complicate revenue forecasting, with potential negative impacts on liquidity and operational results [168]. - Inflationary pressures may arise from increased costs of products, transportation, and wages, although the company has not yet seen a material impact on financial results [170]. Operational Flexibility and Compliance - The company has a noncancelable operating lease for approximately 9,091 square feet of office space in Hayward, California, expiring in October 2025, with lease costs recorded at $51 thousand for Q1 2024 [172][173]. - Contracts with manufacturers and vendors are generally cancelable, allowing flexibility in operations without significant long-term commitments [174]. - Management's estimates and judgments in financial reporting are influenced by macroeconomic factors, which could lead to discrepancies between actual results and forecasts [175]. - Recent accounting pronouncements and significant accounting policies are detailed in the company's Annual Report and Quarterly Report, ensuring compliance with GAAP [177][176].

Table of Contents As filed with the Securities and Exchange Commission on May 8, 2024 Registration No. 333-278383 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TIVIC HEALTH SYSTEMS, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation) Delaware 3845 81-4016391 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification ...

Table of Contents As filed with the Securities and Exchange Commission on April 29, 2024 Registration No. 333-278383 Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TIVIC HEALTH SYSTEMS, INC. (Exact name of registrant as specified in its charter) 25821 Industrial Blvd., Suite 100 Hayward, CA 94545 (888) 276-6888 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) UNITED STATES SECURIT ...